About this trial
Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence.
Aim of the study The aim of the study is to assess the efficacy (adherence) of a diagnostic protocol and the costs of a comprehensive guideline-based approach to the management of fainting and falls in a population of consecutive patients referred to a dedicated multidisciplinary outpatient facility.
Primary endpoint:
1\. Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls.
Secondary endpoints:
1. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis. 2. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations. 3. Analysis of costs per patient of fall and syncope protocols 4. All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.
Inclusion criteria
1. Consecutive patients \>40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall. 2. Fragile patients at risk of falling.
Exclusion criteria:
1. Patients aged \<40 years 2. Patients with dental falls 3. Patients with a known diagnosis of syncope 4. Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consecutive patients aged ≥40 years referred to the Faint & Fall Clinics for assessment of an episode of faint or fall.
Disqualifiers
Patients with age <40 years
Patients with incidental fall
Patients with an established diagnosis of syncope
Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities (e.g: acute myocardial infarction, pulmonary embolism, acute haemorrage)
Trial population
Patients with faint or fall referred to a Syncope Unit for diagnosis and therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Diagnostic pathway
Diagnostic testEach included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways developed in accordance with the most recent guidelines on syncope of the European Society of cardiology and of guidelines on falls of the American and British Geriatrics Societies.
Treatment groups
Trial outcomes
Primary outcomes
Unexplained falls
Point and interval prevalence estimation of patients with unexplained falls, among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.
Secondary outcomes
Final diagnosis
Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls.
Comparison
Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines
Costs
Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient).
Sponsors and contacts
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